MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON AUTOSONIX* ULTRA SHEARS* 5MM INSTRUMENT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 012001

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.The instrument was connected to pmv equipment and registered a mechanical fault.The instrument was disassembled.A crack in the proximal portion of the probe shaft was found.Based on these observations, the cause of the mechanical fault was determined to be the crack in the probe.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend for no cut.Replication of the cracked probe shaft may occur when the probe shaft makes contact with the out tube while the system was energized.Added stress to the tip may cause the probe to touch in the inner tube portion of the instrument, resulting in mechanical failure and/or rendering the instrument inoperable.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.Additional patient information not provided.

Event Description

According to the reporter, during a lap.Living donor nephrectomy procedure, the handpiece was not activated.Another device was opened to continue.No patient harm.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5728926
• MDR Text Key: 47510005
• Report Number: 1219930-2016-00620
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 012001
• Device Catalogue Number: 012001
• Device Lot Number: N4B0891X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1